PlainRecalls
FDA Drug Moderate Class II Terminated

Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03.

Reported: June 1, 2022 Initiated: May 3, 2022 #D-0892-2022

Product Description

Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03.

Reason for Recall

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Details

Units Affected
47 Bottles of 30 Tabs (K1721E); 35 Bottles of 30 Tabs (H3021Q).
Distribution
Within the U.S in FL and CA.
Location
Anaheim, CA

Frequently Asked Questions

What product was recalled?
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03.. Recalled by Preferred Pharmaceuticals, Inc.. Units affected: 47 Bottles of 30 Tabs (K1721E); 35 Bottles of 30 Tabs (H3021Q)..
Why was this product recalled?
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Which agency issued this recall?
This recall was issued by the FDA Drug on June 1, 2022. Severity: Moderate. Recall number: D-0892-2022.